Metabolic Syndrome Clinical Trial
Official title:
A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
The overall purpose of the study is to evaluate the effect of 12 months testosterone
replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in
order to reduce the risk of cardiovascular disease.
The primary study objective is to evaluate changes in insulin sensitivity. The secondary
study objective is to evaluate changes in the prevalence of metabolic syndrome, body
composition, systemic inflammation and symptoms of testosterone deficiency.
This is a single-center, randomized, double-blind, placebo-controlled intervention study,
designed to evaluate the effect of testosterone replacement therapy in testicular cancer
survivors with mild Leydig Cell Insufficiency.
70 subjects will be randomized to receive either testosterone replacement therapy or placebo.
The subjects will be invited for an information meeting where informed consent is signed. If
a subject is suitable for participation in the trial, subject will be randomized to
testosterone replacement therapy or placebo and baseline investigations will be performed.
Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of
testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of
the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at
the end of treatment (52 weeks) and three months after completion of treatment (week 64).
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